Analgesia
Conditions
Keywords
cardiac surgery, regional anesthesia, nociception, enhanced rehabilitation, erector spinae plane block, superficial parasternal intercostal plane block
Brief summary
This clinical trial focuses on an elaborate, propensity-matched, non-inferiority comparison of NOL-guided Superficial Parasternal Intercostal Plane Block (SPIPB) and Erector Spinae Plane Block (ESPB) within the context of open-heart surgery with cardiopulmonary bypass.
Detailed description
A. Ethics Local Ethics Committee approval and Informed Consent from patient or next-of-kin are obtained prior to study enrollment. B. Study enrollment Forty consecutive adult patients scheduled for elective open cardiac surgery under general anesthesia are to receive general anesthesia plus SPIPB. This prospective group of patients will be matched one-to-one to a historical group of 55 patients that underwent open cardiac surgery under general anesthesia combined with ESPB. C. Methods C1. Preinduction * 16-G peripheral intravenous cannula and radial artery catheter. * Five-lead ECG, pulse oximetry, non-invasive and invasive blood pressure monitoring. * Analgesia monitor - the NoL index (PMD200TM, Medasense) finger probe will be connected to the index finger of the non-cannulated hand. * Surgical antibiotic prophylaxis (Cefuroxime 1.5g). * Stress ulcer prophylaxis (omeprazole 40 mg). C2. Superficial Parasternal Intercostal Plane Block (SPIPB) After induction, skin asepsis with chlorhexidine 2% is performed on the anterior chest wall. A high-frequency linear ultrasound probe is positioned parasagittally, 2 cm from midline, bilaterally, at the level of the 4th rib. A 25-G echogenic block needle is inserted at a 20⁰-30⁰ angle in a caudal-to-cephalad direction until the tip of the needle reaches the interfascial plane between the pectoralis major muscle and the internal intercostal muscle. Correct hydrodissection is first certified using normal saline. Subsequently, ropivacaine 0.5% with dexamethasone 8mg/20ml is used and maximum spread is attained by slowly advancing the needle as the interfascial plane splits up ahead. A maximum dose of 3mg/kg ropivacaine is used, corresponding to 1.5 mg/kg per side (e.g., 20 ml ropivacaine 0.5% / side for a 70kg adult). C3. General anaesthesia Monitoring * End tidal CO2 (ETCO2). * Bispectral index (BIS) monitoring (target 40-60). * The nociception monitor (PMD200TM, Medasense) is started before induction. * CVP insertion into the right internal jugular vein under ultrasound guidance. * Urinary catheter, rectal temperature probe placement. Induction * Propofol 1-1.5 mg/kg or Etomidate 0.2-0.3 mg/kg. * Fentanyl 5 mcg/kg. * Atracurium 0.5 mg/kg. Maintenance of anaesthesia * Sevoflurane in O2 during periods of preserved pulmonary blood flow and mechanical ventilation. * Propofol infusion during periods of extracorporeal support. * Atracurium 0.2-0.3 mg/kg/h for adequate neuromuscular blockade. Analgesia 1. Analgesic drugs * Fentanyl: bolus 1.5 mcg/kg. * Paracetamol: 1-gram following induction of general anaesthesia. 2. Analgesia monitoring * NoL index provides a multiderivative assessment of nociception before cardiopulmonary bypass (CPB) initiation. Optimal analgesia is defined as a NoL index of 10-25. * Mean arterial blood pressure (MAP) provides post-CPB decision loop: targets are within ± 15% of MAP recorded during optimum NOL. C4. Postoperative Extubation criteria * Normothermia (T◦ ≥ 36◦C). * No clinical bleeding. * Wakefulness. * Hemodynamic stability (MAP ≥ 60 mmHg and lactate ≤ 2 mmol/L) with minimal vasoactive support (dobutamine \< 5 µg/kg/min and norepinephrine \< 100 ng/kg/min). * Adequate gas exchange: * Tidal volume ≥ 5 ml/kg. * Adequate airway reflex to handle secretions. Analgesia * Paracetamol 1g iv every 6 hours. * Morphine bolus 0.03 mg/kg for NRS \> 3.
Interventions
Immediately after induction of general anesthesia, ropivacaine 0.5% with dexamethasone 8mg/20ml (maximum dose 1.5 mg/kg ropivacaine per each side) is administered in the superficial parasternal intercostal plane using real-time ultrasound guidance.
Immediately after induction of general anesthesia, ropivacaine 0.5% with dexamethasone 8mg/20ml (maximum dose 1.5 mg/kg ropivacaine per each side) is administered in the plane deep to the erector spinae muscle, typically at the level of the 5th thoracic vertebra, under real-time ultrasound guidance.
During general anesthesia, fentanyl is administered according to NOL monitoring.
Morphine 0.03 mg/kg is administered postoperatively for NRS scores equal or higher than 4.
Sponsors
Study design
Intervention model description
Propensity score matching
Eligibility
Inclusion criteria
1. Informed Consent. 2. Elective heart surgery with sternotomy and bypass. 3. Hemodynamic stability prior to induction. 4. Sinus rhythm.
Exclusion criteria
1. Known allergy to any of the medications used in the study. 2. BMI \> 35. 3. Patient refusal to participate in the study. 4. Coagulopathy (INR \> 1.5, APTT \> 45, Fibrinogen \< 150 mg/dl). 5. Non-elective/emergent and/or redo surgery. 6. ASA ≥ 4. 7. Any preoperative hemodynamic support (mechanical or pharmaceutical). 8. Severe LV dysfunction (LVEF ≤ 30%). 9. Severe RV dysfunction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fentanyl consumption (µg/kg) | during intraoperative period | Intraoperative opioid consumption after goal directed monitoring of nociception with the NOL index |
| Morphine consumption (µg/kg) | 48 hours after surgery | Postoperative opioid consumption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Norepinephrine dose (mcg/kg) | intraoperative, 6 hours and 12 hours after surgery | Cumulative dose of Norepinephrine |
| Time to weaning-off norepinephrine | up to 96 hours after surgery | Following ICU admission, the time it takes to stop norepinephrine administration |
| Dobutamine dose (mcg/kg) | intraoperative, 6 hours and 12 hours after surgery | Cumulative dose of Dobutamine |
| Quality of postoperative analgesia | 6 hours, 12 hours, 24 hours and 48 hours after extubation/ICU admission and 1 hour after drain removal | Assessment - numerical rating scale (NRS) (minimum of 0, maximum of 10) |
| Extubated patients | 2 hours after surgery | Number of extubated patients after ICU admission |
| Norepinephrine-free patients | 2 hours after surgery | Number of patients without norepinephrine support |
| Morphine-free patients | 48 hours after surgery | Number of patients who did not require morphine rescue analgesia |
| Time to first dose of morphine | any time for 48 hours | Following admission, the time it takes a patient to request morphine rescue analgesia |
| Time to extubation | up to 24 hours after surgery | Following ICU admission, the time it takes to extubate the patient safely |
Countries
Romania